New Alzheimer's drug sparks backlash over FDA, pricing

The approval of a new Alzheimer's drug has sparked a fierce backlash amid concerns about both price and its effectiveness.

The Biogen drug, marketed under the name Aduhelm, is the first Alzheimer's treatment approved in nearly 20 years.

Yet it comes at a massive cost of $56,000 a year per patient, which is likely to renew pressure on Congress and the Biden administration to pass drug pricing reform legislation.

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Patients and advocates have been desperately searching for an effective treatment, especially for those who experience mild cognitive decline that progresses to Alzheimer's.

They argue that the new drug provides hope and the possibility of a few more years with loved ones. The approval could also be the starting point for future investments into more, better treatments.

"Approvals of the first drug in a new category benefit people living with the disease by invigorating the field, increasing investments in treatments and generating innovation," the Alzheimer's Association said in a statement.

But Aduhelm is not a cure, and the Food and Drug Administration (FDA) made its decision without clear evidence that the drug even works, over the objections of its outside advisory panel.

Now, three doctors on the panel have quit in protest, claiming the FDA did not want to listen to them.

Aaron Kesselheim, a professor of medicine at Harvard Medical School, called the decision “probably the worst drug approval decision in recent U.S. history,” in a letter he submitted when resigning over the decision Thursday.

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The Biogen approval has far-reaching implications not just for the future approvals of experimental drugs with uncertain benefits, but also for the entire U.S. health care system.

Since Alzheimer's disease primarily impacts seniors who are eligible for Medicare, taxpayers will largely foot the bill for the new drug.

An analysis from the nonpartisan Kaiser Family Foundation released Thursday found Aduhelm could cost seniors on Medicare more than $11,000 in annual copays.

If just 500,000 beneficiaries are prescribed Aduhelm, it would cost the program nearly $29 billion a year, more than any other medication. According to Kaiser's Tricia Neuman, who was one of the study's authors, total Medicare spending for all prescription drugs was $37 billion in 2019.

Biogen has said that some 1.5 million Americans with early-stage Alzheimer's will be eligible for the drug. But the FDA also approved its use for patients at any stage of the disease, despite the fact that it was only tested in people with the earliest stage of Alzheimer's.

"Everybody's on the hook," Neuman said. "Taxpayers are on the hook, because Medicare's partially funded by taxpayer dollars, but beneficiaries are on the hook. Not just people who take the drug, but also people who are paying their Part B monthly premiums, which is virtually everyone on Medicare."

The treatment, which is delivered intravenously, is intended to reduce the amount of plaque in the brains of Alzheimer's patients. Brain plaques are thought to be a contributor to Alzheimer's disease.

But the FDA acknowledged the drug had not demonstrated a clear clinical benefit in terms of actually slowing the progression of Alzheimer's. Instead, officials argued that by removing the plaques, Aduhelm “is reasonably likely" to benefit patients, and could potentially slow cognitive decline.

The agency decided to approve the drug under its accelerated approval pathway, which is typically used for rare diseases or drugs with much smaller patient populations.

The approval gives Biogen nine years to complete its clinical studies while continuing to sell the drug.

Drug pricing advocates and progressives in Congress are hoping the sticker shock will provide a renewed push to pass legislation allowing Medicare to negotiate drug prices.

"We all want a better treatment for Alzheimers, but this cost is OUTRAGEOUS. It's time to expand Medicare, empower it to negotiate drug prices for all people, and lower the sky-high price of prescription drugs,"  Rep. Pramila JayapalPramila JayapalAngst grips America's most liberal city Congress must lower the Medicare Age to save the lives of older Americans House Democrats grow frustrated as they feel ignored by Senate MORE (D-Wash.) tweeted Friday.

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Senate Finance Committee Chairman Ron WydenRonald (Ron) Lee WydenDemocrats warn shrinking Biden's spending plan could backfire Democrats release data showing increase in 'mega-IRA' accounts Senate Democrats press administration on human rights abuses in Philippines MORE (D-Ore.) during a hearing on Thursday said the list price for Aduhelm was “unconscionable.” 

"There is little data showing it actually does what the company says it will do," Wyden said.

"Despite that, Aduhelm has an unconscionable list price of $56,000 per year. Let’s understand, it is not a cure, like some other recent breakthrough drugs have been. Patients could be on Aduhelm for years at a time after their diagnosis, multiplying the overall cost of treatment," he added.

Wyden is leading the charge for prescription drug price reform in the Senate, but other lawmakers have been noticeably silent on Aduhelm.

It was not mentioned at all during a Senate Appropriations subcommittee hearing with acting FDA Commissioner Janet Woodcock on Thursday, nor was it brought up in House hearings earlier in the week with Health and Human Services Secretary Xavier BecerraXavier BecerraFederal contractor raises allegations of sexual misconduct at Fort Bliss facility: report Overnight Health Care: CDC advises vaccinated to wear masks in high-risk areas | Biden admin considering vaccine mandate for federal workers Biden administration spending 1M to boost vaccinations in underserved communities MORE.

One drug pricing advocate said part of the hesitancy may be because some lawmakers don’t want to be seen attacking an Alzheimer's drug, especially the first new one in 18 years.

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"Everyone wants to be cognizant of the intense hope for meaningful progress in the treatment of this disease," the advocate said.

Other advocates said the hope is that when more lawmakers see the full cost implications for taxpayers and consumers, there could be a shift in the dynamics.

Still, the politics of drug pricing legislation is fraught, and it's not even clear the Biden administration shares some of the concerns over FDA's controversial approval.

On the Republican side, one of the only lawmakers to mention Aduhelm was Rep. Cathy McMorris RodgersCathy McMorris RodgersLatina lawmakers discuss efforts to increase representation CDC backtracks with new mask guidance CDC: Vaccinated people should now wear masks in high transmission areas MORE (Wash.), who used it as part of a longstanding attack on Speaker Nancy PelosiNancy PelosiOn The Money: Justice Department says Trump's tax returns should be released | Democrats fall short of votes for extending eviction ban House adjourns for recess without passing bill to extend federal eviction ban Photos of the Week: Olympic sabre semi-finals, COVID-19 vigil and a loris MORE’s (D-Calif.) drug pricing plan.

"Every day is a gift. This news gives patients and their families renewed hope," she tweeted on the day the approval was announced. "We need more biomedical innovation so patients have a fighting chance. That’s why we must stop Speaker Pelosi’s radical drug pricing scheme for #FewerCures. It would halt innovation in its tracks."